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				<p class="source">STANDARDS DEVELOPMENT ORGANIZATION</p>
				<img src="../../img/health-care-industry-regulations-and-standards/its.png" width="600px" height="450px"></img>
				<p class="source">INTERNATIONAL TERMINOLOGY STANDARDS</p>
				<p class="content-title">JIC - Joint Initiative Council (International collaborative organization)</p>
				<p class="paragraph">
					Joint  Initiative Council (JIC) is an organization created to have an accepted health informatics standards by addressing issues, gaps, and ineffective standardization 
					efforts through:<br/>
					-  an accepted agreement and decision process for international standardization needs<br/>
					-  making all coordinated standards available through ISO<br/>
					-  an integrated work program<br/>
					- have a particular resolution of overlapping and contradicting standards within the participating work programs of SDO’s
				</p>
				<p class="paragraph">
					Joint Initiative Council consists of the following organizations:
				</p>
					<ul class="paragraph">
						<li>CEN</li>
						<li>HL7</li>
						<li>ISO</li>
						<li>CDISC</li>
						<li>IHTSDO</li>
					</ul>
				<p class="content-title">CEN - European Committee for Standardization</p>
				<p class="paragraph">
					The European Committee for Standardization (CEN, French: Comité Européen de Normalisation) is a non-profit organization was founded in 1961 whose mission is to 
					foster the European economy in global trading, the welfare of European citizens and the environment by providing an efficient infrastructure to interested parties 
					for the development, maintenance and distribution of coherent sets of standards and specifications. CEN is officially recognised as a European standards body by the 
					European Union; the other official European standards bodies are the European Committee for Electrotechnical Standardization (CENELEC) and the European Telecommunications 
					Standards Institute (ETSI).
				</p>
				<p class="content-title">HL7 - Health Level 7</p>
				<p class="paragraph">
					Health Level 7 (HL7) is an international non-profit organization that consists of health care experts and information scientists who work together to create standards 
					for management and integration of electronic healthcare information.  HL7 is one of the founding members of the Joint Initiative Council (JIC), an international council 
					on global informatics standardization.
				</p>
				<p class="paragraph">
					HL7 is an ANSI- accredited standards developing organization and submits ANSI-approved standards for trial use to ISO for approval. HL7 started a set of standards based 
					on a common Reference Information Model (HL7 RIM). These RIM-based standards include the ability to exchange information and support inter-system cooperative processing 
					through messages, electronic documents and recently services. Most data elements exchanged by HL7 standards are encoded in a terminology created and supported by other 
					standards organizations such as IHTSDO, WHO, etc. HL7 also actively collaborates with other accredited healthcare international and country-specific standards groups 
					that address information domains outside of HL7's.
				</p>
				<p class="paragraph">HL7 standard categories:</p>
				<a href="http://www.hl7.org/implement/standards/product_section.cfm?section=1" target="_blank">Section 1: Primary Standards</a>
				<p class="paragraph">-          Includes used and in-demand standards for system integrations, inter-operability and compliance</p>
				<a href="http://www.hl7.org/implement/standards/product_section.cfm?section=2" target="_blank">Section 2: Foundational Standards</a>
				<p class="paragraph">-          Includes and expounds the fundamental tools in building the standards and the technology infrastructure that is being managed by implementers of HL7</p>
				<a href="http://www.hl7.org/implement/standards/product_section.cfm?section=3" target="_blank">Section 3: Clinical and Administrative Domains</a>
				<p class="paragraph">
					-          Includes clinical specialties messaging and document standards.<br/>  
					-          It will be implemented when primary standards are set in place.</p>
				<a href="http://www.hl7.org/implement/standards/product_section.cfm?section=4" target="_blank">Section 4: EHR Profiles</a>
				<p class="paragraph">-          Includes the functional models and profiles for constructing electronic health record management.</p>
				<a href="http://www.hl7.org/implement/standards/product_section.cfm?section=5" target="_blank">Section 5: Implementation Guides</a>
				<p class="paragraph">
					-          Includes  implementation guides and support documents used coinciding with an existing standard.<br/>
					-          Supplemental material for a parent standard</p>
				<a href="http://www.hl7.org/implement/standards/product_section.cfm?section=6" target="_blank">Section 6: Rules and References</a>
				<p class="paragraph">-          Includes software and standards development technical specifications, programming structures and guidelines.</p>
				<a href="http://www.hl7.org/implement/standards/product_section.cfm?section=7" target="_blank">Section 7: Education & Awareness</a>
				<p class="paragraph">-          Includes HL7’s Draft Standards for Trial Use (DSTUs) , current projects, supplemental resources, and adoption of HL7 standards.</p>
				<p class="paragraph">Source: <a href="http://www.hl7.org/implement/standards/" target="_blank"><i>http://www.hl7.org/implement/standards/</i></a></p>
				<p class="content-title">ISO - International Standards Organization</p>
				<p class="paragraph">
					ISO (International Organization for Standardization) is the world’s largest developer of voluntary International Standards. International Standards give state of the art 
					specifications for products, services and good practice, helping to make industry more efficient and effective. Developed through global consensus, they help to break 
					down barriers to international trade.  Currently, 19,000 ISO standards shows the work of more than 260 technical committees (TCs) in manufacturing, technology, security, 
					pharmaceuticals, and many more, including health informatics. <a href="http://www.ahima.org/about/global?tabid=ISO" target="_blank"><i>(http://www.ahima.org/about/global?tabid=ISO)</i></a>
				</p>	
				<p class="paragraph">Key principles in standard development:</p>
				<ol type="1" class="paragraph">
					<li>ISO standards respond to a need in the industry or consumer groups.</li>
					<li>ISO standards are developed by global experts, that are part of a larger group called technical committees which arrange all aspects of the standard.</li>
					<li>ISO standards are developed through a multi-stakeholder process</li>
					<li>ISO standards are based on a consensus</li>
				</ol>
				<p class="paragraph">Source: <a href="http://www.iso.org/iso/home/standards_development.htm" target="_blank"><i>http://www.iso.org/iso/home/standards_development.htm</i></a></p>
				<p class="paragraph">ISO Organizational Structure</p>
					<ul class="paragraph">
						<li>
							The ISO General Assembly<br/>
							- it involves all ISO members annual meetings, agenda usually about the review of the ISO annual report, ISO’s multi-year strategic plan approval, and ISO’s 
							finances.
						</li>
						<li>
							The ISO Council<br/>
							- it consists of the principal officers of ISO and eighteen member bodies, which ANSI is also included. It is responsible for ISO’s multi-year strategic plan 
							and annual budget development. It is also responsible for ISO’s relations with other external organizations, and other political/strategic decisions and the 
							general operations of ISO.
						</li>
						<li>
							The ISO Technical Management Board (ISO/TMB)<br/>
							- it consists of the ISO Vice President for Technical Management and twelve elected member bodies, which ANSI is also included. TMB advises the ISO Council 
							of matters regarding the ISO organization, coordination, strategic planning, and programming of the technical work.
						</li>
						<li>
							ISO Technical Committees and Subcommittees<br/>
							- it consists of industrial, technical, and business experts from government and private agencies who participate as national delegations chosen by the ISO 
							national member institute for a certain country concerned. They develop and consolidate the standards
						</li>
						<li>
							ISO/TC215-Health Informatics<br/>
							- Global health informatics standards are developed<br/>
							- AHIMA serves as delegated secretariat<br/>
							- Over 100 health informatics have been developed
						</li>
					</ul>
				<p class="content-title">CDISC - Clinical Data Interchange Standards Consortium (Clinical research)</p>	
				<p class="paragraph">
					Clinical Data Interchange Standards Consortium (CDISC) is a global, non-profit standards developing organization that has collaborated with consensus-based teams to 
					develop global standards to medical research data.
				</p>	
				<p class="paragraph">
					Mission:<br/>  
					To develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of 
					healthcare.
				</p>
				<p class="paragraph">
					Vision:<br/>  
					To Inform Patient Care and Safety Through Higher Quality Medical Research.
				</p>
				<p class="paragraph">
					In 2001, CDISC has a charter agreement with HL7 to harmonize clinical research and healthcare standards. CDISC has Liaison A status with ISO TC 215 for Healthcare 
					Standards and has been accepted as a member of the Joint Initiative Council (JIC) along with HL7, ISO, and CEN.
				</p>
				<p class="content-title">IHTSDO - International Health Terminology Standards Development Organization</p>	
				<p class="paragraph">
					The International Health Terminology Standards Development Organisation (IHTSDO) is a non-profit Danish association formed in 2007 by 9 charter members from Australia, 
					Canada, Denmark, Lithuania, Netherlands, New Zealand, Sweden, United Kingdom, and the United States. IHTSDO is responsible for maintenance and development of SNOMED CT.
				</p>
				<p class="paragraph">
					SNOMED -  Systematized Nomenclature of Medicine<br/>
					Systematized Nomenclature of Medicine (SNOMED) is designed as a nomenclature of clinical medicine in human and veterinary medicine.
				</p>	
				<p class="paragraph">Brief timeline:</p>
					<ul class="paragraph">
						<li>1965 SNOP –Systematized Nomenclature of Pathology (SNOP) designed by Dr. Arnold Pratt to describe pathological specimen according to their morphology and 
						anatomy (topography) and SNOMED was conceived as an extension of the design.</li>
						<li>1974 SNOMED</li>
						<li>1979 SNOMED II</li>
						<li>1993 SNOMED International 3.0</li>
						<li>1995 SNOMED Microglossary of Signs and Symptoms</li>
						<li>1993-98 SNOMED International versions 3.1-3.5</li>
						<li>2002 First release of SNOMED CT</li>
						<li>2007 All versions of SNOMED acquired by IHTSDO</li>
						<li>2017 All SNOMED versions except SNOMED CT will be formally deprecated by IHTSDO</li>
					</ul>
				<p class="paragraph">Source: <a href="http://en.wikipedia.org/wiki/Systematized_Nomenclature_of_Medicine" target="_blank"><i>http://en.wikipedia.org/wiki/Systematized_Nomenclature_of_Medicine</i></a></p>
				<p class="paragraph">SNOMED CT has provided effective access to information by supporting the development of Electronic Health Records that record clinical information.</p>
				<p class="content-title">ICH - International Conference on Harmonization</p>	
				<p class="paragraph">
					The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) brings together the regulatory authorities 
					and pharmaceutical industry of Europe, Japan and the US to discuss scientific and technical aspects of drug registration. ICH has gradually evolved, to respond to the 
					increasingly global face of drug development, so that the benefits of international harmonisation for better global health can be realised worldwide. ICH's mission is to 
					achieve greater harmonisation to ensure that safe, effective, and high quality medicines are developed and registered in the most resource-efficient manner. 
				</p>	
				<p class="paragraph">
					MedDRA - Medical Dictionary for Regulatory Activities</p>
				<p class="paragraph">	
					Medical Dictionary for Regulatory Activities (MedDRA) is an international, standardized medical terminology dictionary for human use developed by International Conference 
					on Harmonisation of Technical Requirements for Registration of Pharmaceuticals (ICH). It is used by authorities during the regulatory process, from pre-marketing to 
					post-marketing activities, and for data entry, retrieval, evaluation, and presentation. 
				</p>
				<p class="paragraph">Standards: <a href="http://www.meddra.org/sites/default/files/guidance/file/intguide_14_0_english.pdf" target="_blank"><i>http://www.meddra.org/sites/default/files/guidance/file/intguide_14_0_english.pdf</i></a></p>
				<p class="content-title">SCO - SDO Charter Organization (US collaborative organization)</p>	
				<p class="paragraph">SCO - SDO Charter Organization includes the following organizations:</p>
					<ul class="paragraph">
						<li>NCPDP</li>
						<li>ASTM</li>
						<li>ASC X12</li>
					</ul>
				<p class="content-title">NCPDP - National Council for Prescription Drug Programs</p>	
				<p class="paragraph">
					National Council for Prescription Drug Program (NCPDP) is a non-profit organization that uses a consensus-based process for standards development. Competitors as well 
					as trading partners collaborate to achieve solutions they all can support. NCPDP members are pharmacies, pharmacists, physicians, health plans, long term care providers, 
					claims processors, eRx vendors, pharmaceutical manufacturers, and government agencies such as the Centers for Medicare and Medicaid Services (CMS) and Food and Drug 
					Administration (FDA).
				</p>
				<p class="content-title">ASTM - American Society for Testing & Materials</p>	
				<p class="paragraph">
					The American Society for Testing and Materials (ASTM), is an international standards organization that develops and publishes voluntary consensus technical standards 
					for a wide range of materials, products, systems, and services.
				</p>
				<p class="paragraph">The standards produced by ASTM International fall into six categories:</p>
					<ul class="paragraph">
						<li>Standard <a href="http://en.wikipedia.org/wiki/Specification" target="_blank">Specification</a> - defines the requirements to be satisfied by subject of the standard.</li>
						<li>Standard <a href="http://en.wikipedia.org/wiki/Test_Method" target="_blank">Test Method</a> - defines the way a test is performed and the precision of the result. The result 
							of the test may be used to assess compliance with a Standard Specification.</li>
						<li>Standard Practice - defines a sequence of operations that, unlike a Standard Test Method, does not produce a result.</li>
						<li>Standard Guide - provides an organized collection of information or series of options that does not recommend a specific course of action.</li>
						<li>Standard Classification - provides an arrangement or division of materials, products, systems, or services into groups based on similar characteristics such 
							as origin, composition, properties, or use.</li>
						<li>Terminology Standard - provides agreed definitions of terms used in the other standards.</li>
					</ul>
				<p class="paragraph">The quality of the standards is such that they are frequently used worldwide.</p>
				<p class="content-title">ASC X12 - Accredited Standards Committee X12</p>	
				<p class="paragraph">
					The Accredited Standards Committee X12 (also known as ASC X12), chartered by the American National Standards Institute in 1979, develops and maintains the X12 EDI 
					and CICA standards along with XML schemas which drive business processes globally. The membership of ASC X12 includes technologists and business process experts, 
					encompassing health care, insurance, transportation, finance, government, supply chain and other industries.
				</p>
				<p class="content-title">WHO - World Health Organization</p>	
				<p class="paragraph">
					World Health Organization (WHO) was established in April 7, 1948 in Geneva, Switzerland as a specialized agency of the United nations concerning international public 
					health. WHO is also focused on shaping the health research agenda,  setting norms and standards, articulating evidence-based policy options, providing technical support 
					to countries and monitoring and assessing health trends. WHO consists of more than 7000 people from more than 150 countries that work for the organization in 150 WHO 
					offices. In addition to medical doctors, public health specialists, scientists and epidemiologists, WHO staff include people trained to manage administrative, financial, 
					and information systems, as well as experts in the fields of health statistics, economics and emergency relief.
				</p>
				<p class="paragraph">ICD - International Classification of Diseases</p>
				<p class="paragraph">
					International Classification of Diseases (ICD) is the international standard diagnostic tool for epidemiology, health management and clinical purposes 
					that includes the analysis of the general health situation of population groups. ICD is published and maintained by the World Health Organization (WHO). 
					The ICD is a core statistically-based classificatory diagnostic system for health care related issues of the WHO Family of International Classifications (WHO-FIC).
				</p>
				<p class="paragraph">Versions of ICD:</p>
					<ul class="paragraph">
						<li>ICD-6</li>
						<p class="paragraph">
							It was published in 1949 and was the first to be shaped to become suitable for morbidity reporting. Accordingly the name changed from International List of 
							Causes of Death to International Statistical Classification of Diseases.
						</p>
						<li>ICD-7</li>
						<p class="paragraph">
							ICD-7 was held in Paris under the auspices of WHO in February 1955. In accordance with a recommendation of the WHO Expert Committee on Health Statistics, 
							this revision was limited to essential changes and amendments of errors and inconsistencies.
						</p>
						<li>ICD-8</li>
						<p class="paragraph">
							ICD-8 was convened by WHO from 6 to 12 July 1965. This revision was more radical than the Seventh but left unchanged the basic structure of the Classification 
							and the general philosophy of classifying diseases, whenever possible, according to their etiology rather than a particular manifestation. Beginning in 1968, 
							ICDA-8 served as the basis for coding diagnostic data for both official morbidity and mortality statistics in the United States.
						</p>
						<li>ICD-9</li>
						<p class="paragraph">
							ICD-9 was convened by WHO from 30 September to 6 October 1975. In the discussions leading up to the conference, it had originally been intended that there 
							should be little change other than updating of the classification. This was mainly because of the expense of adapting data processing systems each time the 
							classification was revised. ICD-9 included an optional alternative method of classifying diagnostic statements, including information about both an underlying 
							general disease and a manifestation in a particular organ or site. This system became known as the dagger and asterisk system and is retained in ICD-10. A number .
							of other technical innovations were included in ICD-9, aimed at increasing its flexibility for use in a variety of situations. It was eventually replaced by ICD-10, 
							the version currently in use by the WHO and most countries.
						</p>
						<li>ICPM</li>
						<p class="paragraph">
							International Classification of Procedures in Medicine (IVPM) was developed in 1975 and published in 1978. along the time WHO published ICD-9. ICPM is published 
							separately from the ICD disease classification as a series of supplementary documents called fascicles (bundles or groups of items).
						</p>
						<li>ICD-9-CM</li>
						<p class="paragraph">
							International Classification of Diseases, Clinical Modification (ICD-9-CM) is an adaption created by the U.S. National Center for Health Statistics (NCHS) to 
							assign diagnostic and procedure codes associated with inpatient, outpatient, and physician office utilization in the United States.<br/>
							Cooperating Parties <a href="http://www.eicd.com/guidelines/default.htm" target="_blank">(http://www.eicd.com/guidelines/default.htm):</a><br/>
							-          American Hospital Association<br/>
							-          American Health Information Management Association<br/>
							-          Health care Financing Administration<br/>
							-          National Center for Health Statistics
						</p>
						<li>ICD-10</li>
						<p class="paragraph">
							ICD-10 was began in 1983 and in May 1990 the new revision was endorsed by the forty-third World Health Assembly. It allows more than 155,000 different codes 
							and permits tracking of many new diagnoses and procedures which is a greater expansion compared to ICD-9.
						</p>
						<li>ICD-10-CM</li>
						<p class="paragraph">
							ICD-10-CM  was a clinical modification of ICD-10 for diagnosis codes.<br/>
							Cooperating Parties 
							<a href="http://www.acep.org/Legislation-and-Advocacy/Practice-Management-Issues/Physician-Payment-Reform/ICD-10-FAQ/" target="_blank">
								(http://www.acep.org/Legislation-and-Advocacy/Practice-Management-Issues/Physician-Payment-Reform/ICD-10-FAQ/):</a><br/>
							-          National Center for Health Statistics/CDC (NCHS)<br/>
							-          Centers for Medicare and Medicaid Services (CMS)<br/>
							-          American Hospital Association (AHA)<br/>
							-          American Health Information Management Association (AHIMA)
						</p>
						<li>ICD-10-CA</li>
						<p class="paragraph">ICD-10-CA was an adaption of Canada for ICD-10 and was developed by the Canadian Institute for Health Information for morbidity classifications.</p>
						<li>ICD-11</li>
						<p class="paragraph">ICD-11 is currently developed on an internet-based workspace called iCAT (Collaborative Authoring Tool) platform and is expected to be submitted 
							by 2017 to WHO’S World Health Assembly.</p>
					</ul>
				<p class="content-title text-underline">Other Terminology Standards</p> 
				<p class="content-title">CPT - Current Procedural Terminology</p>
				<p class="paragraph">
					The Current Procedural Terminology (CPT) is a registered trademark of American Medical Association (AMA) and through the CPT Editorial Panel they 
					maintained the CPT code set. CPT code set is a medical code set that gives a description of medical, surgical, and diagnostic services. CPT code set is also design to 
					communicate uniform information about medical services and procedures among physicians, coders, patients, accreditation organizations, and payers for administrative, 
					financial, and analytical purposes.There are three types of CPT code: Category I, Category II, and Category III.
				</p>
				<p class="paragraph">Category I CPT Code(s)</p>
					<ul class="paragraph">
						<li>Codes for evaluation and management: 99201–99499</li>
						<li>Codes for anaesthesia: 00100–01999; 99100–99150</li>
						<li>Codes for surgery: 10021–69990</li>
						<li>Codes for Radiology: 70010-79999</li>
						<li>Codes for pathology and laboratory: 80047–89398</li>
						<li>Codes for medicine: 90281–99099; 99151–99199; 99500–99607</li>
					</ul>
				<p class="paragraph">Category II CPT Code(s)</p>
					<ul class="paragraph">
						<li>Composite measures 0001F-0015F</li>
						<li>Patient management 0500F-0575F</li>
						<li>Patient history 1000F-1220F</li>
						<li>Physical examination 2000F-2050F</li>
						<li>Diagnostic/screening processes or results 3006F-3573F</li>
						<li>Therapeutic, preventive or other interventions 4000F-4306F</li>
						<li>Follow-up or other outcomes 5005F-5100F</li>
						<li>Patient safety 6005F-6045F</li>
						<li>Structural Measures 7010F-7025F</li>						
					</ul>
				<p class="paragraph">Category III CPT Code(s) – Emerging technology (Category III codes: 0016T-0207T)</p>
				<p class="paragraph">
					CPT coding is similar to ICD-9 and ICD-10 coding, except that it identifies the services rendered rather than the diagnosis on the claim. CPT is currently 
					identified by the Centers for Medicare and Medicaid Services (CMS)  as Level 1 of the Health Care Procedure Coding System.
				</p>
				<p class="paragraph">LOINC - Logical Observations Identifiers Names & Codes</p>
				<p class="paragraph">
					Logical Observations Identifiers Names & Codes (LOINC) was developed in 1994 by Regenstrief Institute as a coding system for laboratory and other clinical measures. 
					LOINC codes are universal identifiers and are used in electronic messages. The purpose is to assist in the electronic exchange and gathering of clinical results 
					(such as laboratory tests, clinical observations, outcomes management and research)  to assist in the electronic exchange and gathering of clinical results (such as 
					laboratory tests, clinical observations, outcomes management and research). LOINC has two main parts: laboratory LOINC and clinical LOINC. Clinical LOINC contains a 
					sub-domain of Document Ontology which captures types of clinical reports and documents.
				</p>
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